Arthrex® AR-8928BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867049123), received between Aug 30, 2016 and May 28, 2025 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN HAMSTRING SURGERY THE SWIVELOCK ANCHOR BROKE DURING INSERTION INTO THE BONE. NO PARTS REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098487 ↗
• MalfunctionApr 17, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ACHILLES SPEED BRIDGE SURGERY THE ANCHOR COULD NOT BE INSERTED INTO THE BONE. THE PLASTIC HAS SLID OVER THE SWIVE LOCK SCREW. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855186 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ASK SURGERY THE ANCHOR HAS BEEN PULLED OUT OFF THE BONE. IT WAS NOT NECESSARY TO DRILL A NEW HOLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558502 ↗
• MalfunctionApr 15, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SPEEDBRIDGE ACHILLES TENDON SURGERY THE ANCHOR COULD NOT BE SCREWED IN DESPITE THE THREAD WAS PRECUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DA A SECOND SURGERY. UPDATE SWIT 15-FEB-2022: THE ANCHOR / THE IMPLANT DID NOT COME OFF THE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112091 ↗
• MalfunctionMar 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE ANCHOR COULD BE INSERTED, BUT THE TIP OF THE DRIVER WAS DEFORMED. THE SURGERY COULD BE COMPLETED TODAY WITHOUT ANY PROBLEMS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888794 ↗
• InjuryFeb 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 2/5/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8928BC-C ACHILLES SPEEDBRIDGE WAS USED IN SURGERY FOR THE ACHILLES TENDON ENTHESIS ON (B)(6) 2023. ONE MONTH AFTER SURGERY, BONE RESORPTION WAS OBSERVED AROUND THE ANCHOR. IT HAS BEEN REPORTED THAT FOLLOW-UP HAS BEEN CONTINUED TO DATE.

  Patient problems: Necrosis; Tissue Breakdown

  MAUDE report 18778515 ↗
• InjuryNov 15, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ON (B)(6) 2023 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8928BC-CP BIOCOMPOSITE ACHILLES SPEEDBRIDGE IMPLANT DELIVERY WAS USED DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2017. AFTER THE SURGERY, THE PATIENT COMPLAINED OF PAIN DUE TO THE PROTRUSION OF THE ANCHOR. A REVISION SURGERY WAS PERFORMED TO REMOVE THE ANCHOR ON (B)(6) 2017. THE PATIENT RECOVERED WELL AFTER THE REVISION SURGERY. NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS INFORMATION WAS OBTAINED FROM CASE DATA INCLUDED IN A SUMMARY OF AN ACADEMIC CONFERENCE PRESENTATION. PER THE ARTHREX SUBSIDIARY EMPLOYEE, THE SALES REPRESENTATIVE DOES NOT KNOW THE EXACT DATE OF THE REVISION SURGERY, BUT IT IS ESTIMATED TO BE ON (B)(6) 2017. NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS THESE SURGERIES.

  Patient problems: Pain

  MAUDE report 18140389 ↗
• InjuryOct 6, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT IN 2021 AN ABLATION OF HAGLUND EXOSTOSIS AND A REFIXATION WITH ACHILLES SPEEDBRIDGE WAS PERFORMED ((B)(6), SURGEON NAME: (B)(6)). THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT COMPLICATIONS. AFTER THE SURGERY THE PATIENT COMPLAINED ABOUT PAIN DUE TO A MINIMAL EDEMA IN THE ACHILLES TENDON INSERTION AREA. ON (B)(6) 2023 AN ANCHOR RECOVERY DEBRIDEMENT WAS PERFORMED TO RETRIEVE THE IMPLANT FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: Swelling/ Edema

  MAUDE report 17890118 ↗
• MalfunctionSep 8, 2023Positioning Failure; Defective Device; Positioning Failure; Defective Device

  IT WAS REPORTED THAT DURING AN ACHILLES SPEEDBRIDGE AND FHL TRANSFER SURGERY UPON INSERTION OF A SINGLE SWIVEL LOCK FROM THE SPEED BRIDGE KIT, THE INSERTER WRAPPED ITSELF AROUND THE SCREW AND THE MECHANISM SEIZED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-2324BCC). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711887 ↗
• MalfunctionJul 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACHILLES SPEEDBRIDGE SURGERY THE PLASTIC OF THE ANCHOR GOT BENT DURING THE INSERTION. THE FAILURE DID NOT HAVE AN IMPACT AND THE SURGERY COULD BE FINISHED SUCCESSFULLY WITHOUT FURTHER ISSUES. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 21-JUN-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE DRIVER OF THE REPORTED DEVICE GOT BENT. THE ANCHOR WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335313 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A COMP FT SURGERY THE DEVICE GOT DAMAGED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 24-MAR-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR BROKE DURING THE SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785316 ↗
• MalfunctionMay 9, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT THE AR-8928BC-CP ANCHOR BROKE IN HALF DURING INSERTION. THIS OCCURRED DURING AN ACHILLES TENDON REPAIR ON (B)(6) 2022. THE BROKEN FRAGMENT WAS RETRIEVED. THE SURGEON FELT FIXATION WAS SUFFICIENT AND CONTINUED WITH THE PROCEDURE. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES AND THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337613 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE WHILE PLACING THE LATERAL ANCHOR IN HEEL. THE SURGERY CONTINUED SINCE THE ANCHOR WAS ENOUGH FIXED ACCORDING TO THE SURGEON. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336488 ↗
• MalfunctionNov 8, 2021Separation Problem

  IT WAS REPORTED THAT DURING AN ACHILLES SPEED-BRIDGE SURGERY FOR HAGLUND'S DEFORMITY THERE WAS NO ANCHOR ON ONE OF THE PRE-LOADED DEVICES AND ON INSERTION OF ONE OF THE DISTAL ROW ANCHORS FROM THE SAME PACK, THE ANCHOR SPLIT ALMOST IMMEDIATELY. NO PART OF THE DEVICE BROKE OFF. AN ADDITIONAL DEVICE PACK HAD TO BE OPENED TO COMPLETE THE PROCEDURE. IT WAS ALSO NOTICED THAT THERE WAS NO USE BY DATE PRINTED ON THE STICKER FROM THE PACKAGING. THE SECOND BOX HAD A DATE ON THE STICKER. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771254 ↗
• InjuryApr 8, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE IMPLANT THAT WAS INSERTED ON (B)(6) 2019 TO REPAIR ACHILLES TENDON; ALSO AT THE TIME WAS A REMOVAL OF A BONE SPUR. THE PATIENT ( FEMALE (B)(6)) HAD BLISTERS ALL OVER HER FOOT; SHE WENT TO A DERMATOLOGIST AND WAS GIVEN A TOPICAL THAT DID NOT IMPROVE THE PROBLEM. ON (B)(6) SHE VISITED THE ORIGINAL DOCTOR WITH A RASH AT THE SITE. THAT DOCTOR GAVE HER AN ANTIBIOTIC OINTMENT WHICH DID NOT IMPROVE THE PROBLEM; SHE RETURNED TO THE DERMATOLOGIST WHO GAVE HER STEROID INJECTIONS AND CREAM AND THE SITE HAS IMPROVED. HER LAST VISIT TO THE ORIGINAL DOCTOR WAS (B)(6) 2020 AND SHOWED AN IMPROVEMENT AT THE SITE.

  Patient problems: Rash

  MAUDE report 9935576 ↗
• InjuryMar 26, 2020Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD UNDERGONE A HAGLUNDS AND ACHILLES PROCEDURE ON HER FOOT ON (B)(6) 2018. HER MEDICAL RECORDS NOTE THAT THE SURGEON HAD IMPLANTED AN ARTHREX SPEEDBRIDGE IMPLANT, AR-8928BC-CP. PATIENT HAS A KNOWN ALLERGY TO LATEX AND SURGEON ALSO NOTED IN HER RECORDS THAT HER IMPLANT NEEDED TO BE A METAL COMPOSITION. PATIENT ALSO DISCLOSED THAT SOMETIME IN HER PAST SHE HAS EXPERIENCED ISSUES WHEN WEARING COSTUME JEWELRY AND SO HAS SINCE AVOIDED SUCH JEWELRY. SINCE THE SURGERY THE PATIENT HAS DEVELOPED NUMEROUS ISSUES IN HER FOOT. THE FOOT IS SWOLLEN WITH WHAT APPEARS TO BE A LARGE GROWTH. SHE HAS A STINGING/ PINS AND NEEDLES FEELING IN THE TOP OF FOOT AND HAS DEVELOPED WHAT LOOKS SIMILAR TO A PSORIASIS TYPE OUTBREAK ON THE BOTTOM OF HER FOOT. SHE CONTINUALLY HAS LEG CRAMPS AT NIGHT AND WHEN STEPPING OUT OF BED HAS A TREMENDOUS AMOUNT OF PAIN IN HER FOOT. SHE HAS UNDERGONE A YEAR OF INTENSE THERAPY TO HELP WITH THE HYPERSENSITIVITY ISSUES SHE IS ALSO EXPERIENCING BUT ALTHOUGH SOME RELIEF THE ISSUES HAVE CONTINUALLY GOTTEN WORSE SINCE THE SURGERY. THE PATIENT HAS REQUESTED THE MATERIAL COMPOSITION OF THE IMPLANT COMPONENTS WHICH WILL BE PROVIDED TO HER. THE P

  Patient problems: Cramp(s); Hypersensitivity/Allergic reaction; Pain; Rash; Swelling

  MAUDE report 9883039 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  AN INITIAL CLAIM NOTICE WAS RECEIVED FROM THE PATIENT'S ATTORNEY IN (B)(6) 2018. NO PART NUMBERS OR INCIDENT INFORMATION WAS PROVIDED AT THAT TIME TO CONFIRM AN ARTHREX PRODUCT WAS INVOLVED. ON (B)(6) 2019, THE PATIENT'S LEGAL REPRESENTATIVE PROVIDED MEDICAL RECORDS WHICH REPORTED THE PATIENT UNDERWENT A HAGLUND'S OSTEOTOMY, GASTROC RECESSION (LEFT) ON (B)(6) 2016. DURING THE 2016 PROCEDURE, AN ARTHREX AR-8928BC-CP, LOT 10061945 (IMPLANT SYSTEM, BIO-COMPOSITE ACHILLES SPEEDBRIDGE) DEVICE WAS IMPLANTED. THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PAIN UNTIL INJURING HIS FOOT. THE MEDICAL RECORDS NOTE THE PATIENT WAS DOING WELL POST-SURGERY; HOWEVER, THE PATIENT HAD AN OPEN ¿DEHISCENCE¿ OF THE DISTAL WOUND FOR OVER A YEAR THAT WENT UNRESOLVED. THE PATIENT STILL USED LIDOCAINE PATCHES BUT HAD STOPPED TAKING GABAPENTIN. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE ER FOR PAIN AFTER DEVELOPING A NEW OPENING ALONG THE DISTAL INCISION. THE PATIENT WENT TO THE ER WHEN THE WOUND ON HIS HEAL RE-OPENED. ER RECORDS NOTE THAT THE PATIENT REPORTED PAIN IN HIS ANKLE AND HEEL, INCREASED FEVER, NAUSEA, AND INCREASED REDNESS TO THE HEAL. A CT OF HIS ANKLE NOTED OSTEOMYELITIS OF THE CALCANEUS.

  Patient problems: Erythema; Fever; Nausea; Pain; Wound Dehiscence

  MAUDE report 8317219 ↗
• InjuryNov 9, 2018Break

  IT WAS REPORTED THAT TWO OF THE ANCHORS FAILED DURING INSERTION; THE FIRST IMPLANT STRIPPED ON INSERTION AND IT WAS REMOVED. THE SECOND IMPLANT BROKE AT INSERTION; ABOUT 25% OF IT REMAINS IN THE PATIENT. ANOTHER IMPLANT WAS USED IN THE SITE OF THE FIRST IMPLANT; THERE WAS NO IMPLANT PLACED ON TOP OF THE FRAGMENT. CASE WAS AN ACHILLES SPEEDBRIDGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8054680 ↗
• InjuryMay 10, 2018Break

  IT WAS REPORTED THAT THE SWIVELOCK IS BROKEN-OFF. THERE IS A SMALL FRAGMENT REMAINING IN THE PATIENT. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. IT WILL REMAIN INSIDE THE PATIENT. AR-8928BCCP WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502471 ↗
• InjuryFeb 15, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHERE AN ARTHREX IMPLANT WAS IMPLANTED. SHE HAD TO HAVE A REVISION ON (B)(6) 2017 TO HAVE THE DEVICE EXPLANTED. PATIENT STATED THAT HER EXPLANTED DEVICE WAS SENT IN FOR EVALUATION AND SHE WANTED TO RECEIVE THE EVALUATION FINDINGS. HOWEVER, NO REPORT OF THIS INCIDENT WAS FOUND. PATIENT HAD NO FURTHER DETAILS AT THE TIME OF CALL, ADDITIONAL INFORMATION HAS BEEN REQUESTED. SALES REP HAS ALSO BEEN CONTACTED FOR ASSISTANCE. SALES REP HAD BEEN CONTACTED THE SAME DAY BY THE SURGEON AND REP HAS INFORMED US THAT THE DEVICE WAS NOT SENT TO ARTHREX, IT WAS SENT TO A PATHOLOGY LAB FOR CULTURE/TESTING. PATIENT WAS INFORMED AND STATED SHE WAS AWARE BUT ALSO WANTS IT EVALUATED BY ARTHREX. PATIENT ALSO STATED THAT ALL CULTURES WERE NEGATIVE FOR INFECTION. PATIENT STATED THAT THE DEVICE WAS SECURE AT THE TIME OF EXPLANTATION AND THAT THE SURGEON HAD TO DIG TO GET IT OUT. ADDITIONAL INFORMATION AND STATUS OF DEVICE HAS BEEN REQUESTED OF BOTH THE PATIENT AND THE SALES REP. PART NUMBERS HAVE NOT BEEN PROVIDED AT TIME OF INITIAL REPORT. FOLLOW-UP INVESTIGATION: PATIENT ORIGINAL SURGERY TOOK PLACE (B)(6) 2017. THE FOLLOWING PART WAS IMPLANTED AT TIM

  Patient problems: No Code Available

  MAUDE report 7273914 ↗
• InjuryFeb 8, 2018Device Dislodged or Dislocated

  A SURGEON HAS REPORTED TO THE SALES REPS THAT THE PATIENT HAS REPORTED ONGOING PAIN IN THE AREA OF THE IMPLANTS POST ACHILLES SPEEDBRIDGE SURGERY THAT WAS PERFORMED ON (B)(6) 2016. DURING THE PROCEDURE THE BONE WAS PREPARED USING THE DRILL AND DRILL GUIDE PROVIDED IN THE ACHILEES SPEEDBRIDGE KIT. FOLLOW-UP INVESTIGATION: PATIENT BEGAN EXPERIENCING PAIN 2-4 MONTHS AFTER THE (B)(6) 2016 PROCEDURE. LOT NUMBER OF THE AR-8928BC-CP WAS 10052318. MRI REVEALED PATCHY BONE EDEMA AROUND THE ANCHOR. PATIENT HAS ALSO DEVELOPED LYMPH EDEMA. PATIENT REPORTED A FALL. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017 AND ONE DISTAL ROW 4.75 BIO-COMPOSITE SWIVELOCK ANCHOR, FROM THE ORIGINAL ACHILLES SPEEDBRIDGE CONSTRUCT, WAS REPLACED WITH A 5.5 BIO-COMPOSITE SWIVELOCK ANCHOR. THE (B)(6) 2017 REVISION PROCEDURE WAS REPORTED TO HAVE BEEN PERFORMED AS A RESULT OF PATIENT FALL WHICH OCCURRED IN (B)(6) 2017. THE 4.75 MM SWIVELOCK WAS EXPLANTED DURING THE (B)(6) 2017 PROCEDURE BECAUSE IT WAS DISCOVERED TO HAVE BEEN 50% PULLED OUT. THE SWIVELOCK WAS NOT BROKEN. THE EXPLANTED SWIVELOCK ANCHOR THAT WAS EXPLANTED WAS DISPOSED OF AT TIME OF PROCEDURE. SINCE THE SECOND (B)(6) 2017 PROCEDURE PATIENT IS REPORTED

  Patient problems: Edema; Fall; Pain

  MAUDE report 7251307 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information

  A SURGEON HAS REPORTED TO THE SALES REPS THAT THE PATIENT HAS REPORTED ONGOING PAIN IN THE AREA OF THE IMPLANTS POST ACHILLES SPEEDBRIDGE SURGERY THAT WAS PERFORMED ON (B)(6) 2016. DURING THE PROCEDURE THE BONE WAS PREPARED USING THE DRILL AND DRILL GUIDE PROVIDED IN THE ACHILEES SPEEDBRIDGE KIT. FOLLOW-UP INVESTIGATION: PATIENT REPORTED PAIN THROUGHOUT THE FIRST NINE MONTHS POST THE (B)(6) 2016 PROCEDURE. PATIENT HAS HAD NO OTHER REACTION SYMPTOMS BESIDES PAIN. PATIENT HAD NO REPORTED INJURY OR TRAUMA POST THE (B)(6) 2016 PROCEDURE. ON (B)(6) 2017 SAME SURGEON PERFORMED A SECOND SURGERY WHICH WAS A SUBCHONDROPLASTY. IT WAS REPORTED THAT THE PATIENT'S SECOND (B)(6) 2017 SURGERY WAS PERFORMED TO RELIEVE PATIENT PAIN FROM THE ORIGINAL ACHILLES SPEEDBRIDGE SURGERY. NO ARTHREX PRODUCT WAS EXPLANTED DURING THE (B)(6) 2017 PROCEDURE. DURING THE SECOND SURGERY SUBCHONDROPLASTY TECHNIQUE THE SURGEON USED NON-ARTHREX PRODUCT CALCIUM PHOSPHATE. SINCE THE SECOND SURGERY PATIENT IS REPORTED TO STILL BE EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 7251299 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACHILLES REPAIR ON (B)(6) 2017. THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE THE PROCEDURE AND THE SURGICAL AREA IS WARM TO THE TOUCH. ACCORDING TO THE PATIENT THE SURGEON IMPLANTED TWO ARTHREX DEVICES. ON (B)(6) 2017 THE PATIENT SAW HER SURGEON DUE THE PAIN AND HE PRESCRIBED AN ORAL STEROID AND ADVISED THAT SHE WAS HAVING A REACTION. THE SURGEON ALSO ADVISED THAT IMPLANTS TAKE 6-8 MONTHS TO ABSORB.

  Patient problems: Pain; Reaction

  MAUDE report 6875402 ↗
• InjuryJul 13, 2017Loose or Intermittent Connection

  IT WAS REPORTED BY PATIENT THAT HE HAD A PREVIOUS SURGERY USING THE ARTHREX SPEEDBRIDGE. HE REPORTED THE ANCHOR CAME LOOSE AND WAS LATER REMOVED. PATIENT BELIEVES ANOTHER ANCHOR IS LOOSE. ADDITIONAL INFORMATION OBTAINED 6/8/2017: OP REPORT NOTES (B)(6) 2016 PROCEDURE: THE FOLLOWING PROCEDURES WERE PERFORMED: EXCISION OF CALCANEAL EXOSTOSIS- POSTERIOR RIGHT CALCANEUS, SECONDARY REPAIR OF RIGHT ACHILLES TENDON, EXCISION OF ACCESSORY NAVICULA WITH KIDNER POSTERIOR TIBIAL TENDON TRANSFER, INTRAOPERATIVE USE OF FLUOROSCOPY AND APPLICATION OF WELL-PADDED BELOW-KNEE POSTERIOR SPLINT. DURING THE PROCEDURE AN ARTHREX SPEEDBRIDGE WAS USED IN PROCEDURE TO REPAIR THE ACHILLES. AN ARTHREX 3.5 MM BIOCOMPOSITE ANCHOR WAS USED IN PROCEDURE AFTER PLANING THE BONE TO ALLOW FOR TENODESIS AND WAS PLACED INTO THE ANATOMIC INSERTION OF THE POSTERIOR TIBIAL TENDON AT THE MEDIAL AND PLANTAR NAVICULA. OP REPORT NOTES THE REPAIR AS "EXCELLENT". AT TIME OF SURGERY PATIENT (B)(6) PATIENT STATES A BURNING PAIN STARTED LATE (B)(6) 2016. PAIN CONTINUED AND A BUMP COULD BE FELT IN THE AREA OF THE ANCHOR ON THE LOWER RIGHT IF VIEWING REAR OF FOOT. X-RAY WAS TAKEN TO CONFIRM ISSUE. PATIENT STATES THERE WAS NO TRAUM

  Patient problems: No Code Available; Pain

  MAUDE report 6710140 ↗
• InjuryDec 16, 2016Break; Split

  IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR ON (B)(6) 2016, THE SURGEON WAS ATTEMPTING TO INSERT THE FOURTH AR-8928BC-CP, SWIVELOCK. DURING INSERTION, THE ANCHOR SPLIT DOWN THE MIDDLE. ABOUT 5MM OF THE ANCHOR BROKE AND WAS REMOVED FROM THE PATIENT. THE SURGEON HAD USED THE TAP FROM THE ACHILLES SPEED BRIDGE. THE SEATED DEPTH OF THE REMAINDER OF THE IMPLANT WAS ABOUT 3/4 AND THE SURGEON WAS HAPPY WITH THE FIXATION THE REMAINING PORTION OF THE ANCHOR PROVIDED. NO PATIENT INJURY. BONE QUALITY WAS REPORTED TO BE AVERAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6180330 ↗